Commercial Operations Manager

7 days ago


north yorkshire, United Kingdom Warman O'Brien Full time

Warman O'Brien is seeking a highly skilled Commercial Operations Manager to join our team. As a Commercial Operations Manager, you will play a critical role in ensuring compliance with regulatory and quality standards for commercial activities related to the distribution, sale, and marketing of pharmaceutical products.

Job Summary:

  • Serve as the designated Qualified Person (QP) for commercial activities, responsible for ensuring compliance with all relevant regulatory requirements and guidelines.
  • Oversee the release of pharmaceutical products for commercial distribution, ensuring that all necessary documentation and testing have been completed in accordance with applicable regulations and company standards.

Responsibilities:

  1. Review and approve commercial documentation, including batch records, labelling, packaging, and distribution records, to ensure accuracy, compliance, and alignment with regulatory requirements.
  2. Collaborate with cross-functional teams, including production, quality assurance, regulatory affairs, and marketing, to support commercial activities and resolve any quality-related issues.
  3. Conduct regular audits and inspections of commercial activities, including manufacturing facilities, warehouses, and distribution centres, to ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant quality standards.
  4. Act as a point of contact for regulatory authorities and participate in regulatory inspections, ensuring timely and appropriate responses to any findings or queries.

Requirements:

  • Bachelor's degree in pharmacy, pharmaceutical sciences, or a related field. Advanced degrees and certifications are a plus.
  • Prior experience as a Qualified Person (QP) within the pharmaceutical industry, with a focus on commercial activities, is essential.
  • In-depth knowledge of global regulatory requirements, including but not limited to EU GMP, FDA regulations, ICH guidelines, and other relevant industry standards.

The estimated salary for this position is $120,000 per year. We offer a comprehensive benefits package and opportunities for career growth and development within our organization.



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